Evidence map›Paper›PMID 33825965›Full record

Trial reportLung2021

Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant.

Alyn H Morice, Surinder S Birring, Jaclyn A Smith, Lorcan P McGarvey, Jonathan Schelfhout, Allison Martin Nguyen, Zhi Jin Xu, Wen-Chi Wu, David R Muccino, Mandel R Sher

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Lung, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02612610 (A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02612610 phase2completednot on this map

A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough

TypeinterventionalSponsorAfferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2015 to 2016Enrolled253ConditionsRefractory Chronic CoughArmsGefapixant, Placebo (for gefapixant)
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  19. Chronic cough: new insights and future prospects.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Alyn H MoriceRespiratory Research Group, Hull York Medical School, Cottingham, UK. a.h.morice@hull.ac.uk.ORCID 0000-0002-6135-9610
Surinder S BirringCentre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Jaclyn A SmithDivision of Infection, Immunity, and Respiratory Medicine, University of Manchester, and Manchester University NHS Foundation Trust, Manchester, UK.
Lorcan P McGarveyWellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Jonathan SchelfhoutMerck & Co., Inc., Kenilworth, NJ, USA.
Allison Martin NguyenMerck & Co., Inc., Kenilworth, NJ, USA.
Zhi Jin XuMerck & Co., Inc., Kenilworth, NJ, USA.
Wen-Chi WuMerck & Co., Inc., Kenilworth, NJ, USA.
David R MuccinoMerck & Co., Inc., Kenilworth, NJ, USA.
Mandel R SherCenter for Cough, Largo, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis analysis assesses clinical characteristics of patients with refractory chronic cough (RCC) or unexplained chronic cough (UCC) enrolled in a phase 2 study to better understand this patient population.

methodsPatients with RCC/UCC lasting for ≥ 1 year and cough severity visual analog scale (VAS) score of > 40 mm at screening were eligible. Demographics, clinical characteristics, and medical history were collected at baseline. Cough-related measures included cough severity VAS, Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), and a structured cough-trigger questionnaire. Medication history included all medications 30 days before screening and chronic cough treatments within 1 year before screening. Data were summarized using descriptive statistics.

resultsPatients (N = 253; female, 76%; mean age, 60 years) had severe (mean cough severity VAS, 57.5 mm) and long-lasting (median duration, 11 years) cough. The most burdensome self-reported aspects included psychological and social factors (LCQ) and cough frequency and intensity (CSD). Patient-reported triggers were consistent with cough hypersensitivity (e.g., 95% to 96% reported irritation or tickle in throat). Common reported comorbidities included gastroesophageal reflux disease (GERD; 56%), allergic rhinitis (47%), and asthma (30%); 12% of patients had been diagnosed with all 3 conditions. The most common prior medications included inhaled or oral steroids (21%), antihistamines (15%), and antacids (15%).

conclusionPatients with RCC/UCC had severe, long-lasting, and burdensome cough with clinical features of cough hypersensitivity. Many patients had been diagnosed with GERD, allergic rhinitis, and asthma but had a persistent cough despite treatment of these conditions.

trial registrationClinicalTrials.gov, NCT02612610; registered November 20, 2015.

Indexed as

AdultAgedAsthmaBenzenesulfonamidesChronic DiseaseCoughFemaleGastroesophageal RefluxHumansMaleMiddle AgedPyrimidinesQuality of LifeRhinitis, AllergicSeverity of Illness IndexSulfonamidesBenzenesulfonamidesGefapixantPyrimidinesSulfonamidesCough hypersensitivity syndromeIdiopathic chronic coughPersistent coughRefractory coughTroublesome cough

Identifiers

PMID33825965
PMCPMC8053171

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.